Datex-Ohmeda Recalls

FDA
2
Total Recalls
1
Agencies
Jul 2004
First Recall
Jul 2004
Latest Recall

Showing 1-2 of 2 recalls

FDA

Multi Absorbers, reference number 8003138

Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.

Recall letters dated February 12, 2003 requested that the product be removed from use and returned.

FDA

Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)

Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.

'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.